Quality of life outcomes of combination zidovudine-didanosine-nevirapine and zidovudine-didanosine for antiretroviral-naive advanced HIV-infected patients

Raffaella Bucciardini, Albert W. Wu, Marco Floridia, Vincenzo Fragola, Daniela Ricciardulli, Carlo Tomino, Liliana E. Weimer, Maria F. Pirillo, Marco Mirra, Massimo Marzi, Giacomo Giannini, Clementina M. Galluzzo, Mauro Andreotti, Maurizio Massella, Stefano Vella

Research output: Contribution to journalArticle

Abstract

Objectives: To evaluate the quality of life outcomes in antiretroviral-naive patients randomized to zidovudine plus didanosine versus zidovudine plus didanosine plus nevirapine for treatment of advanced HIV disease (the Istituto Superiore di Sanita 047 trial). Design: A 48-week randomized, double-blind trial. Methods: Sixty patients were enrolled and evaluated over 24 weeks. Quality of life was assessed using a modified version of the Medical Outcomes Study-HIV Health Survey. For analysis, we calculated two summary scores reflecting the physical (PHS) and the mental (MHS) components of health. Results: Although the three-drug combination was superior at inducing immunologic and virologic responses, the two-drug regimen was superior for both PHS and MHS, especially at week 8 where differences were both statistically and clinically significant (5.8 and 9.2 points, respectively, P < 0.02 for both). Quality of life changes paralleled trends in body weight and Karnofsky performance status score. Conclusion: Although a three-drug antiretroviral therapy regimen was superior in terms of short term virologic/immunologic response, the two-drug regimen was better in terms of quality of life. In general, triple therapy remains the most effective treatment option. However, quality of life assessments can yield results that may be discordant with and complementary to those obtained using conventional endpoints. Comparative trials should collect a comprehensive range of outcome measures, including patient-reported quality of life, in order to provide clinicians and patients with additional information that may influence treatment decisions. (C) 2000 Lippincott Williams and Wilkins.

Original languageEnglish (US)
Pages (from-to)2567-2574
Number of pages8
JournalAIDS
Volume14
Issue number16
DOIs
StatePublished - Nov 27 2000

Keywords

  • Clinical trials
  • HIV-treatments
  • Quality of life

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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    Bucciardini, R., Wu, A. W., Floridia, M., Fragola, V., Ricciardulli, D., Tomino, C., Weimer, L. E., Pirillo, M. F., Mirra, M., Marzi, M., Giannini, G., Galluzzo, C. M., Andreotti, M., Massella, M., & Vella, S. (2000). Quality of life outcomes of combination zidovudine-didanosine-nevirapine and zidovudine-didanosine for antiretroviral-naive advanced HIV-infected patients. AIDS, 14(16), 2567-2574. https://doi.org/10.1097/00002030-200011100-00020